A Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Participants

An Open-Label, Sequential Design Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Subjects

The purpose of this study is to assess the potential effects of rifampin on the pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PCI-32765; Drug: Rifampin

Detailed Description

This is an open-label (all people know the identity of the intervention), single center (study conducted at one site), sequential study (it is a design in a single group of participants are administered one or more study medication in a sequence) to evaluate the potential effects of rifampin on the pharmacokinetics of PCI-32765 in healthy participants.The study consists of 3 phases: screening phase (21 days prior to first dose of study medication), treatment phase (14 days), and a follow up phase (10 to 12 days after the last dose of study medication). In the treatment phase, a single dose of PCI-32765 560 mg will be administered orally on Day 1 and Day 11. Rifampin 600 mg (2 X 300 mg) will be administered orally on Days 4 to 13; followed by a single dose of PCI-32765 on Day 11. Follow up will be continued until Day 14. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The duration of the study will be approximately for 45 days.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants should be healthy on the basis of physical examination, medical history, vital signs, electrocardiogram, the results of blood biochemistry and hematology tests and a urinalysis performed at screening
• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• Participants with medically significant cardiac disease, hematologic, lipid abnormalities, significant pulmonary disease (bronchospastic respiratory), diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease and infectious disease
• Abnormal clinical laboratory and physical examination and vital signs
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 3 days before the first dose of the study drug is scheduled
• Positive to human immunodeficiency virus-type 1 (HIV-1) or HIV-2 test and hepatitis A, B or C infection at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCI-32765 + Rifampin; Participants will recieve a single oral dose of PCI-32765 560 mg on Day 1 and Day 11 along with rifampin; and rifampin 600 mg from Day 4 to Day 13.	Drug: PCI-32765; PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11; Drug: Rifampin; Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration of PCI-32765	Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration of PCI-32765	Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
Area under the plasma concentration-time curve from time 0 to infinite time of PCI-32765	Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
Obsreved plasma concentrations of metabolite PCI-45227	Day 1 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 2, Day 3, Day 4, Day 11 (Predose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours), Day 12, Day 13 and Day 14
Number of participants with adverse events	up to 45 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Healthy participants; Rifampin; CYP3A4; PCI-32765; PCI-45227
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: CR100929; PCI-32765CLL1010 (Other Identifier: Janssen Research & Development, LLC)